NA 357.370Recalls & reported problems
Synthes GmbH · RETAINING RING FOR 357.369 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982196040), received between Apr 3, 2019 and Apr 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2019Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE, THE (TROCHANTERIC FIXATION NAIL) TFN HELICAL BLADE INSERTER ATTACHMENT SCREW BROKE WHILE INSERTING THE HELICAL BLADE. REPORTEDLY, NUT FELL OFF THE INSTERTER CAUSING IT TO COME APART AND HAD TO MALLET IT TO GET IT DISCONNECTED FROM HELICAL BLADE. IT WAS NOTED ALSO THAT WHILE INSERTING THE HELICAL BLADE, THE END OF THE HELICAL BLADE COUPLING SCREW BROKE OFF LEAVING THE SHAFT IN THE INSERTER STILL ATTACHED TO THE HELICAL BLADE. THE HELICAL BLADE WAS SUCCESSFULLY INSERTED AND IT TOOK 20 MINUTES TO TAKE OFF THE INSERTER. FINALLY, THE BOLT CUTTERS WERE USED TO CUT THE SHAFT ABOVE WHERE IT WAS ATTACHED TO THE HELICAL BLADE. THE AIMING ARM WAS THEN ATTACHED BACK AND DISTALLY LOCKED TO FINISH THE CASE. WHILE MALLETING THE HELICAL BLADE, THE END OF THE COUPLING SCREW BROKE LEAVING THE SHAFT OF THE CONNECTING SCREW IN THE HELICAL BLADE INSERTER. THE FOLLOWING DEVICES WERE DAMAGED WHEN TRYING/ATTEMPTING TO REMOVE THE INSERTER: ONE (1) BUTTRESS/COMPRESSION NUT, ONE (1) BLADE GUIDE SLEEVE, AND ONE (1) AIMING ARM. THERE WERE FRAGMENTS GENERATED FROM A BROKEN DEVICE. THE FRAGMENTS WERE REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. THERE WERE THIRTY (30) MI
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8479621 ↗
Other INSTRUMENT, COMPRESSION devices
- ATTUNE 2545-01-042Depuy (Ireland) · INSTRUMENT, COMPRESSION153 reports
- ATTUNE 2545-11-041Depuy (Ireland) · INSTRUMENT, COMPRESSION78 reports
- ATTUNE 2545-05-550Depuy (Ireland) · INSTRUMENT, COMPRESSION54 reports
- ATTUNE 2545-05-551Depuy (Ireland) · INSTRUMENT, COMPRESSION34 reports
- NA 03.111.021Synthes GmbH · INSTRUMENT, COMPRESSION32 reports
- ATTUNE 2545-05-552Depuy (Ireland) · INSTRUMENT, COMPRESSION27 reports
- NA 03.211.400Synthes GmbH · INSTRUMENT, COMPRESSION25 reports
- VIPER PRIME 286750083Medos International Sàrl · INSTRUMENT, COMPRESSION18 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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